ANKASCIN 568-P red yeast rice for lowering HbA1c and blood sugar

Effect of ANKASCIN 568-P Products on Decreasing HbA1c and Regulating Blood Glucose- A Double-blind, Placebo-controlled Clinical Research

This study will test whether taking ANKASCIN 568-P red yeast rice capsules daily can lower HbA1c and help control blood sugar in adults with high blood sugar or metabolic syndrome.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 20 Years and up
• Sex: All
• Sponsor: SunWay Biotech Co., LTD. (Industry-sponsored)
• Locations: 1 site (Taipei)
• Trial ID: NCT05737342 on ClinicalTrials.gov

What this trial studies

This is a randomized, double-blind, placebo-controlled trial lasting 24 weeks with about 80 participants. Subjects are assigned to take two capsules daily of ANKASCIN 568-P (440 mg per capsule) or matching placebo, with biochemical blood tests at baseline and at weeks 4, 12, and 24. Investigators will track HbA1c, fasting glucose, blood lipids, blood pressure, body measurements, and monitor liver, kidney, and thyroid function. The protocol includes screening, a treatment period, and a discontinuation follow-up to observe longer-term changes.

Who should consider this trial

Good fit: Adults over 20 with BMI 18–35 who have fasting glucose 100–125 mg/dL or HbA1c 5.7–6.4%, or people with diabetes not taking hypoglycemic drugs, who do not have serious comorbid diseases and can comply with study visits, are ideal candidates.

Not a fit: People with advanced diabetes on glucose-lowering medications, significant liver or kidney dysfunction, recent major cardiovascular disease, pregnant or breastfeeding women, or those outside the BMI range are unlikely to benefit from joining this protocol.

Why it matters

Potential benefit: If successful, this could provide an oral supplement option to modestly lower HbA1c and improve blood sugar control, potentially delaying the need for prescription glucose-lowering drugs for some patients.

How similar studies have performed: Red yeast rice is well known for lipid-lowering effects due to monacolin compounds, but evidence that it improves long-term glycemic control is limited and results from prior small studies have been mixed.

Eligibility criteria

Inclusion Criteria:

1. Men or non-pregnant women over 20 years old (women of childbearing age are not allowed to become pregnant or breastfeed during the study) adults who are sane and able to communicate.
2. 18≦BMI≦35.
3. Blood routine examination (CBC; Complete blood count): the mean corpuscular volume MCV should not be less than 70 fL.
4. Blood glucose level measurement meets any of the following conditions:

(1) The fasting blood sugar is between 100∼125 mg/dL, and the doctor judges that there is no need to use hypoglycemic drugs for the time being.

(2) Or the glycosylated hemoglobin is between 5.7∼6.4%, and the doctor judges that the use of hypoglycemic drugs is not needed for the time being.

(3) Diabetic patients who have no willingness to take medicine and have not taken hypoglycemic drugs in the past month.

5\. Those without other serious diseases (cancer, heart failure, myocardial infarction, liver cirrhosis, moderate to severe liver and kidney dysfunction, stroke, etc.).

6\. Hypoglycemic drugs are not allowed to be used during the trial. If the condition changes and the use of hypoglycemic drugs is required, the trial must be withdrawn.

7\. During the test period, the daily routine and eating habits should be maintained without deliberately changing them.

Exclusion Criteria:

1. Blood pressure: systolic blood pressure ≧ 200 mmHg or diastolic blood pressure ≧ 140 mmHg.
2. Moderate or severe liver and kidney dysfunction (generally refers to serum aminopyruvate converting enzyme (SGPT) and serum glutamate phenylacetate transaminase (SGOT) are more than 3 times higher than the upper limit of normal value or have been diagnosed Liver cirrhosis, or glomerular filtration rate eGFR≦30 ml/min/1.73m2).
3. Pregnant or lactating women.
4. Diabetic patients taking hypoglycemic drugs or insulin injections.
5. Those who take traditional Chinese medicine mainly red yeast rice.
6. Have undergone surgery within one month.
7. Combined with serious diseases such as heart, liver, kidney and hematopoietic system, mentally ill patients who do not meet the inclusion criteria, who do not eat the test samples according to the regulations, so that the efficacy cannot be judged or the incomplete data affect the judgment of efficacy or safety.

Where this trial is running

Taipei

• Tri-Service General Hospital, National Defense Medical Center, Taipei city, — Taipei, Taiwan (Recruiting)

Study contacts

• Principal investigator: WEN-HUI FANG, Ph. D. — Chief of Family medicine department
• Study coordinator: Sean Lin

Conditions High Blood Sugar; Metabolic Syndrome